C2 REVISION Hip 9045.10.225

GUDID 08033390024891

Straight Handle for Rasp

LIMACORPORATE SPA

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

Primary Device ID	08033390024891
NIH Device Record Key	b5a045ed-bb34-4bc7-8ae0-07cb223d126d
Commercial Distribution Status	In Commercial Distribution
Brand Name	C2 REVISION Hip
Version Model Number	9045.10.225
Catalog Number	9045.10.225
Company DUNS	432066322
Company Name	LIMACORPORATE SPA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390024891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140975

FDA Product Code

JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented